Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946034
Recruitment Status : Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Raymond Chung, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE October 26, 2016
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
Reduction in biomarkers of CKD progression [ Time Frame: 52 Weeks ]
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2016)
  • Safety and Tolerability of Viekira Pak treatment in CKD patients [ Time Frame: 12 weeks ]
    Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests and vital signs
  • Efficacy of Viekira Pak treatment in CKD patients [ Time Frame: 24 weeks ]
    Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.
  • Effect on patient quality of life [ Time Frame: 52 Weeks ]
    Quality of life will be assessed by on treatment and post-treatment patient fatigue questionnaire (FACIT-F) scoring.
  • Effect on patient quality of life [ Time Frame: 52 Weeks ]
    Quality of life will be assessed by on treatment and post-treatment patient physical and mental health summary scores from the SF-36 questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Official Title  ICMJE Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen
Brief Summary Two arm, open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.
Detailed Description

The objective of arm 1 of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.

The objective of arm 2 is to evaluate Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Chronic Hepatitis C
Intervention  ICMJE
  • Drug: Viekira Pak ± ribavirin
    12 weeks treatment with AbbVie Viekira Pak ± ribavirin
    Other Name: AbbVie 3D regimen
  • Drug: Mavyret
    12 weeks treatment with AbbVie Mavyret
Study Arms  ICMJE
  • Experimental: Treatment 1
    12 week therapy with Viekira Pak ± ribavirin
    Intervention: Drug: Viekira Pak ± ribavirin
  • Experimental: Treatment 2
    12 week therapy with Mavyret
    Intervention: Drug: Mavyret
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female ≥ 18 year of age
  2. HCV genotype 1 ≥ 1000 IU/mL
  3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Uncontrolled depression or psychiatric disease
  3. History or presence of any form of cancer within 3 years of enrollment
  4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
  5. Uncontrolled cardiovascular or pulmonary disease
  6. Experiencing symptoms attributed to uremia
  7. Anticipated need to begin renal replacement therapy in the next 6 months
  8. History of kidney transplant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02946034
Other Study ID Numbers  ICMJE 2016P001822
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Results data will be shared with the study sponsor and publication of data is anticipated.
Responsible Party Raymond Chung, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP